CMO and R&D Summit West Speakers

Laurie Burke, RPh, MPH

Former Director, Study Endpoints and Labeling Development (SEALD), ONDIO, CDER / Founder

FDA / LORA Group

Laurie Burke, RPh, MPH, is the Founder of LORA Group, LLC, an advisor of global medical product development organizations regarding best practices in outcomes research, regulatory strategy, product labeling and advertising. Her primary interest is the development and incorporation of state of the science measures as clinical trial endpoints.
Ms Burke was a career US Public Health Service officer with a retired rank of Captain (O6). Her 29-year PHS assignment was with the US Food and Drug Administration, Center for Drug Evaluation and Research, where she maintained responsibilities related to epidemiologic research in drug safety, evidence review for promotion and advertising claims, and regulatory policy development and oversight related to labeling and outcomes measurement in clinical trials. Ms Burke led the FDA response to FDAMA section 114 at the time of its original implementation beginning in 1997 giving FDA regulatory authority over the dissemination of economic information by medical product manufacturers to managed care organizations. She was the lead author of the FDA Patient-Reported Outcomes Guidance published as draft in 2006 and final in 2009. Ms Burke collaborated extensively on matters of PRO measurement with the European Medicines Agency, the National Institutes of Health, other US Department of Health and Human Services agencies.
Ms Burke is an Affiliate Associate Professor at the University of Maryland School of Pharmacy and a past International Society for Pharmacoeconomics and Outcomes Research Board Member currently maintaining a leadership role in several ISPOR PRO Task Forces. Her academic degrees include a Master of Public Health in Epidemiology from the Uniformed Services University of the Health Sciences and a bachelor of science in pharmacy from the University of Kansas.

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